Daptomycin

Product NDC
60505-6229
11-digit product format
605056229
Labeler code
60505
Product ID
60505-6229_bd835d4b-9824-4797-9df1-8237d3b6fca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
APOTEX CORP.
Application
ANDA215316
Marketing category
ANDA
Marketing start
2022-02-23
Substance
DAPTOMYCIN
Active strength
500 mg/10mL
Pharmacologic classes
Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Daptomycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPTOMYCIN500 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNWQ5N31VKK
Rxcui403920

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151aProduct name120250724
223d8260-7a4e-4ebd-9635-845422d6a8adProduct name920240909
ca803a62-3799-476f-bbc6-024f77cb0320Product name420240207
cad85d83-8fb9-49f8-a5a6-a399af412964Product name120230922
8e59a5ed-f224-4156-b534-1ae4d0b6dfd7Product name120230721
ea2c89ab-e8f8-425f-9693-c923fa1e1703Product name120220929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-6229-4Daptomycin10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,107
60505-6229-4Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6229-4EA - Each60505-622996a6e220-8348-418d-8246-2c20ceb664c012022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6229DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP.]7Current NDC, Legacy NDC, 2 package rows20240120_4bf6cd85-dfc8-44d4-b569-3ff27b9d3c09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSN4bf6cd85-dfc8-44d4-b569-3ff27b9d3c097
403920daptomycin 500 MG InjectionSCD4bf6cd85-dfc8-44d4-b569-3ff27b9d3c097

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6229-4605056229041 VIAL, SINGLE-USE in 1 CARTON (60505-6229-4) / 10 mL in 1 VIAL, SINGLE-USE2022-02-230000-00-00NoNoCurrent